FDA Adverse Event
Malfunction
Summary report: N
STONETOME¿
MDR report key: 7464651
·
Received April 26, 2018
Report
- Report Number
- 3005099803-2018-01423
- Event Type
- Malfunction
- Date Received
- April 26, 2018
- Report Date
- March 31, 2018
- Product Code
- LQR
- PMA / PMN Number
- K946358
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
FOR THE 4 EVENTS REPORTED UNDER EXEMPTION NUMBER E2012065, ALL 4 COMPLAINT DEVICES WERE RETURNED. THREE (3) EVENTS WERE FOUND TO HAVE A ROOT CAUSE OF OPERATIONAL CONTEXT AND 1 EVENT WAS FOUND TO HAVE A ROOT CAUSE OF HANDLING.
Description of Event or Problem · 1
THE MANUFACTURER REPORT IS BEING SENT AS A REQUIREMENT UNDER SUMMARY REPORTING EXEMPTION APPROVAL NUMBER E2012065 FOR PRODUCT CODE LQR. THIS REPORT COVERS 4 REPORTED EVENTS OF TOMES WIRE BROKEN. THE PATIENTS' SEX AND AGE ALONG WITH ALL OTHER DEMOGRAPHIC INFORMATION IS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 309169 | STONETOME¿ | DISLODGER, STONE, BILIARY | LQR | M00535110 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |